Twyneo is an investigational, antibiotic-free, fixed-dose combination of benzoyl peroxide, 3%, and tretinoin, 0.1%, cream for the treatment of acne vulgaris, using our proprietary drug-delivery technology. If approved, it has the potential to be the first acne treatment on the market that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are each approved as single-agent products for the treatment of acne. They are frequently prescribed together, however, they have not yet been marketed as a combination product because benzoyl peroxide causes degradation of tretinoin when combined in the same formulation. In Twyneo, each ingredient is encapsulated in a silica shell, which is designed to release the ingredients slowly over time. The FDA has accepted our NDA for Twyneo with a PDUFA goal date set for August 1, 2021.
The safety and efficacy of Twyneo have not been established. Twyneo is a registered trademark of Sol-Gel Technologies, Ltd.